Apparatus for tubal occlusion

Abstract

Disclosed herein is a device adapted for occluding the ovarian pathway of a female body for sterilization purposes. The device delivers RF energy to wound tissue at a desired location within at least one fallopian tube and implants a porous foam plug adjacent to the wounded tissue at said location. Depending on the plug's pore sizes, vascularized tissue may grow into the plug to prevent or discourage the formation of scar tissue around the plug and/or a vascularized capsule may form around the plug, which limits the patient's foreign body response so that the capsule does not constrict around the plug.

1. A device for occluding the ovarian pathway of a female body comprising:
 a catheter body having a distal end and a proximal end; 
 a wounding segment extending distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position; 
 a wounding element disposed on the wounding segment; 
 at least one plug housed within at least one of the wounding segment and catheter body and sized and dimensioned to be implanted into a target site within the ovarian pathway leading from the ovaries to the uterus of a female body, the at least one plug defining numerous interconnecting pores; 
 a holding rod longitudinally fixed and disposed at least partially within the catheter body, the holding rod being positioned proximal to the at least one plug to prevent movement of the at least one plug relative to the target site during proximal movement of the wounding segment from the extended position toward the retracted position; and 
 wherein the device is operable so that proximal movement of the wounding segment from the extended position toward the retracted position disposes the at least one plug at the target site without moving, and without requiring movement of, the catheter body relative to the female body. 
 
     
     
       2. The device of  claim 1 , wherein the wounding element comprises an RF electrode array. 
     
     
       3. The device of  claim 2 , wherein the RF electrode array comprises four electrodes laterally spaced relative to each other along the longitudinal axis of the wounding segment. 
     
     
       4. The device of  claim 3 , wherein the electrodes are ring electrodes, each disposed circumferentially on the outer surface of the wounding segment. 
     
     
       5. The device of  claim 2 , wherein the RF electrode array is adapted to deliver 0.1 to 5 watts of RF energy to the target site for 5 to 60 seconds. 
     
     
       6. The device of  claims 2 , wherein the RF electrode array is adapted to deliver RF energy to the target site while maintaining tissue temperatures at the target site between 40-80° C. for a period of 5 to 60 seconds. 
     
     
       7. The device of  claim 1 , further comprising at least one temperature sensor disposed on the wounding segment and adapted to monitor temperatures at the target site. 
     
     
       8. The device of  claim 1 , wherein pores are sized to encourage at least one of vascularized tissue ingrowth and vascularized capsule growth. 
     
     
       9. The device of  claim 1 , wherein the pores are sized between at least one of (i) 1-20 microns and (ii) 40-200 microns. 
     
     
       10. The device of  claim 1 , wherein the at least one plug is a foam plug or a reticulated foam plug. 
     
     
       11. The device of  claim 10 , wherein the at least one plug comprises silicon. 
     
     
       12. The device of  claim 1 , wherein the at least one plug comprises a long lasting biologically tolerable and biologically inert material. 
     
     
       13. The device of  claim 1 , wherein the at least one plug further comprises a solid nonporous core. 
     
     
       14. A system for occluding the ovarian pathway of a female body comprising:
 an occlusion device comprising: 
 a catheter body having a distal end and a proximal end; 
 a wounding segment extending distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position; 
 a wounding element disposed on the wounding segment, wherein the wounding element comprises an RF electrode array; 
 at least one plug housed within at least one of the wounding segment and catheter body and sized and dimensioned to be implanted into a target site within the ovarian pathway leading from the ovaries to the uterus of a female body, the at least one plug defining numerous interconnecting pores; 
 a holding rod longitudinally fixed and disposed within the catheter body, the holding rod being positioned proximal to the at least one plug to prevent movement of the at least one plug relative to the target site during proximal movement of the wounding segment from the extended position toward the retracted position; 
 wherein the occlusion device is operable so that proximal movement of the wounding segment from the extended position toward the retracted position disposes the at least one plug at the target site without moving, and without requiring movement of, the catheter body relative to the female body; and 
 a power supply for supplying power to the RF electrode array. 
 
     
     
       15. The system of  claim 14 , further comprising an endo scope or hysteroscope including a working channel for receiving the occlusion device and operable for viewing the precise placement of the occlusion device within the ovarian pathway. 
     
     
       16. A device for occluding the ovarian pathway of a female body comprising:
 a catheter body having a distal end and a proximal end; 
 a wounding segment positioned distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position; 
 a wounding element disposed on the wounding segment; 
 a plug housed within the wounding segment to be implanted into a target site within the ovarian pathway leading from the ovaries to the uterus of a female body; 
 a holding rod longitudinally fixed and disposed at least partially within the catheter body, the holding rod being positioned proximal to the plug to prevent movement of the plug relative to the target site during proximal movement of the wounding segment from the extended position toward the retracted position; and 
 wherein the device is operable so that proximal movement of the wounding segment from the extended position toward the retracted position disposes the plug at the target site without moving, and without requiring movement of, the catheter body relative to the female body. 
 
     
     
       17. The device of  claim 16  wherein the wounding element includes one of resistive heating elements, direct laser irradiation, laser heated elements, microwave, ultrasound, piezo-electric abrasion, hypothermia, cryothermia, chemical ablation, and mechanical and physical abrasion. 
     
     
       18. The device of  claim 16  wherein the wounding segment includes energized electrodes located between ground electrodes. 
     
     
       19. The device of  claim 16  further comprising a pull wire coupled to the wounding segment adapted to permit proximal movement of the wounding segment.